The following data is part of a premarket notification filed by Rayner Surgical Inc with the FDA for C-flex System Single Use Disposable Injector, Model R-inj-02.
| Device ID | K052651 |
| 510k Number | K052651 |
| Device Name: | C-FLEX SYSTEM SINGLE USE DISPOSABLE INJECTOR, MODEL R-INJ-02 |
| Classification | Folders And Injectors, Intraocular Lens (iol) |
| Applicant | RAYNER SURGICAL INC SACKVILLE ROAD Hove, East Sussex, GB Bn3 6wq |
| Contact | Mark Mullaney |
| Correspondent | Mark Mullaney RAYNER SURGICAL INC SACKVILLE ROAD Hove, East Sussex, GB Bn3 6wq |
| Product Code | MSS |
| CFR Regulation Number | 886.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-26 |
| Decision Date | 2006-01-19 |
| Summary: | summary |